MAUDE Adverse Event Report: COLOPLAST TITAN; PENILE PROSTHESIS

Model Number E52920

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 11/08/2017

Event Type  Injury  

Event Description

The patient reported persistent erectile dysfunction over the past 5 years, since having the device.The device appeared to have fluid loss.

• Brand Name: TITAN
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST; minneapolis MN 55411
• MDR Report Key: 7049375
• MDR Text Key: 92756337
• Report Number: MW5073484
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E52920
• Device Catalogue Number: ER8075
• Device Lot Number: 5812700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 88